Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy - Full Text View

Sponsor:	Conrad, Erich J., M.D.
Collaborator:	Forest Laboratories
Information provided by:	Conrad, Erich J., M.D.
ClinicalTrials.gov Identifier:	NCT00595699

Purpose

This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.

Condition	Intervention	Phase
Major Depression Temporal Lobe Epilepsy	Drug: escitalopram Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-Blind, Placebo-Controlled Study.

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Depression Epilepsy

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Conrad, Erich J., M.D.:

Primary Outcome Measures:

Montgomery And Asberg Depression Rating Scale [ Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinician's Global Impression Severity and Improvement subscales [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Double-blind	Drug: placebo Placebo
1: Experimental escitalopram group	Drug: escitalopram 10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a confirmed diagnosis of temporal lobe epilepsy
Subject meets DSM-IV criteria for Major Depression
MADRS greater than or equal to 15 at screening and baseline
Subject between ages of 18 and 65
Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center

Exclusion Criteria:

Any other primary axis I diagnosis other than Major Depression
The presence of psychogenic, non-epileptic seizures
A history of non-response to two or more antidepressants given for an adequate therapeutic trial
The presence of substance abuse or dependence in past six months
The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
Pregnancy or nursing
Any subjects with suspected mental retardation, psychotic disorder or dementia
Subjects whose anticonvulsant medication regimen includes phenobarbital
Individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4
Cognitive-behavioral therapy will not be allowed during the course of the study. Other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study.
Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
Individuals with a known hypersensitivity to escitalopram or any of its ingredients
Individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595699

Contacts

Contact: Lisa S Gulledge, MS

504-412-1560

lgulle@lsuhsc.edu

Locations

United States, Louisiana
LSU Anxiety and Mood Disorders Clinic	Recruiting
New Orleans, Louisiana, United States, 70115
Sub-Investigator: James G Barbee, M.D.

Sponsors and Collaborators

Conrad, Erich J., M.D.

Forest Laboratories

Investigators

Principal Investigator:

Erich J Conrad, M.D

LSUHSC

More Information

No publications provided

Responsible Party:	LSUHSC ( Erich J. Conrad, M.D. )
Study ID Numbers:	LXP-MD-116, LSUHSC IRB #6653
Study First Received:	January 3, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00595699 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Epilepsies, Partial
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Brain Diseases
Mental Disorders
Therapeutic Uses

Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Depression
Nervous System Diseases
Central Nervous System Diseases
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Epilepsy
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010